Evaluation of Finasteride Stability, Drug-Excipient Compatibility Studies, and Quality Control of Solid Pharmaceutical Formulations in the Market

    May 2020 in “ riUfes (Universidade Federal do Espírito Santo) ”
    Igo Pinheiro Lopes e Sousa
    TLDR Finasteride is stable except in high pH, and lactose and magnesium stearate should be replaced in formulations.
    The study evaluated the stability and compatibility of finasteride, a drug used for conditions like androgenetic alopecia, with various excipients in pharmaceutical formulations. Using High Performance Liquid Chromatography, the research confirmed the method's precision and robustness, with finasteride showing stability under most stress conditions except basic hydrolysis at pH above 12.7. Compatibility tests revealed that most excipients were compatible, though lactose and magnesium stearate were not, suggesting replacements with mannitol and stearic acid. Quality control of market formulations showed that only two manipulated formulations failed to meet pharmacopoeial standards, highlighting the need for improved formulation development to meet legal and clinical expectations.
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